Monday, April 04, 2011

Pradaxa, Your Days are Numbered

It was supposed to be the greatest thing since sliced bread: the first new oral anticoagulant in 50 years that did not require INR testing in the majority of patients. It's time to effective anticoagulation was measured in hours instead of days. There were even some data that suggested a possible propensity to lower intracranial bleeding rates compared its older counterpart, warfarin.

But the world changed for dabigatran (marketed by Boehringer-Ingelheim Pharmaceuticals as Pradaxa®) yesterday. That was the day the new proposed rule for structuring Accountable Care Organizations (ACOs) was proposed by CMS and published online with its addendum of 65 quality measures.

Sadly, dabigatran (and probably most of the other direct thrombin inhibitors being developed) will no longer represent "quality care" for patients with heart failure and atrial fibrillation. Quality measure #51 requires the use of warfarin, not dabigatran, for atrial fibrillation in patients with heart failure.

I am not a dabigatran drug representative, nor economist, but it is clear that innovative medications that have the potential to improve our patients' quality of living by unshackling them from the constant blood testing and phone tag with doctors required by warfarin have been officially deemed expensive and bad medicine.

Sadly, this new ACO rule is already outdated and permits the perpetuation of the status quo. The rule steps backward to tie our patients to warfarin instead of newer anticoagulant agents in the name of an "important quality measure." Once in place, this rule will tie our heart failure patients to our overburdened health care system by requiring all of those with atrial fibrillation to get their at-least-monthly prothrombin times (blood thinning levels) and then contacting their ACO for instructions for warfarin dosage adjustments.

Even more concerning, it will take legislative action (and probably expensive additional "Comparative Effectiveness Research" trials) to change these rules once they become law, and then only after a non-elected body decides it should do so. Never mind that such a study has been done.

This, my friends, is life with an ACO in the years ahead. It is for your own good and the good of our country. I'm sorry I will no longer be able to use my clinical judgment on your behalf soon to select the anticoagulant that's best for you. (Pradaxa, it's been fun.) But rest reassured: my quality scorecard, tied to my salary, will look impeccable. After all, I'll soon be practicing nothing but "quality" and "cost effective" medicine in our new Accoutable Care Organizational structure.

30 comments:

Wes, Come on, it's just a proposed rule and an easy fix. I'm not a particular fan of ACO's, but I don't see this point - on requiring warfarin in management of afib - as an argument for or against ACO's.

It's an example of bureaucracy, I'll admit, but then you'd have to admit the endless, wasteful paperwork that goes hand-in-hand with the private insurance-based health care system.

I have submitted all the paperwork to get a home INR test kit but so far my Cardio group has 'failed' to sign off on it. Of course the current lab where I get blood drawn and sent to be read and sent back to my Cardio group coumadin clinic who then calls me are all tied together in a neat and billing package...

Anon at 2:21 - what about those people who cannot take warfarin because it interacts with some other medication they need?

My mother who passed away last summer, had lung cancer (no, before you ask, she has never smoked nor did anybody in the family). She had a rare ALK-EML mutation for which there was an effective drug (crizotinib) in clinical trials. She had aetrial fibrillation a few years prior and was on warfarin. To be accepted into the trial she had to stop warfarin. She could've gone on daily injections of heparin but this wouldn't really help with quality of life, so after talking to the cardiologist they decided it was an acceptable risk to take given as she had regular heartbeat for the few years after that episode.

Without going into much details - we don't know the exact cause of death. The clinical trial drug kept her cancer from progressing and without any noticeable side effects. It could've been pneumonia (as local doctors thought where ambulance took her), but it could've been a blood clot (as a doctor in famous cancer center who called me later thought). If it were a blood clot maybe she wouldn't have it if this new drug had been available and she would've been on it.

Now, I've no idea if this new drug would've helped my mother if it had been available to live a little longer. Nor do I know if the clinical trial would've allowed it or if the new drug interacts with it. What I have read is that this new drug has fewer interactions with other drugs than warfarin. Which means it can potentially allow people to take it together with other potentially life-saving medications without having to make a choice.

wes i am being put into a conner by my pc dr he wants to take me off warfin and start pradaxa after reading ur info i do not think i will do it i have a hard time keeping my level right but like others have said at least they know what to do for me while on warfin

Several years back, my husband experienced lower extremity blood clots and a PE. Due to his Crohn's disease and short bowel, his INR levels on Coumadin were too erratic. He was switched to Lovenox and clotted while on Lovenox. He was then successfully switched to Arixtra. All went well for awhile - until last week. He clotted while on Arixtra. Fortunately, Pradaxa is available. And, fortunately, our insurance is covering it. He is now home from the hospital and taking his twice daily Pradaxa. We'll have to wait and see how it works out for him.

so, now what....???? My first question was "how to measure 'how' thin the blood is"....told it just does it correctly.....not so sure after reading this....now what do you do or say to a doc who really wants and thinks this is the best drug for you....besides of course,finding another doc.....as for me..I have barrets esph. and don't think this is a good idea for me...and mercy..the cost...unreal....most of all there is no way to STOP the blood from thinning with this in the case of an accident...that I don't like at all.........what if there is just a history of PE but no A-fib...then why take this new drug ....this is almost like "when it sounds too good to be true...it probably is"...it is good as long as it works without harm...but an accident could be serious if bleeding can't be controled quickly...all this has done is serve to confuse me more then I was before...my INR was so low last doc visit...this is what he was thrilled to tell me about and insist I use........Now what...what specialty of doc would be the best to follow my INR levels....an internist is who told me to take this new great drug that I really have bad feelings toward the more I read...just can't deal with NOT being able to measure how well or not well it is thinning the blood...and why doesn't food types like high in Vit.K have anything to do with the thinning itself?

If you feel the current ACO rule is unacceptable, why don't you take action to change it? Legislators are just that - legislators. They need input from people like yourself. You can't fix a problem if you don't know there's a problem to begin with.

For an individual person, a blog with reach is one of the best ways I know to express my views to effectively change things. Given the corporate control and command of health care delivery today, do you have a better way to express the front line's concerns? If so, let us know.

I greatly appreciate your post on this matter and hope you and all your readers will take the next step and post your objections/proposed modifications to this proposed rule per the CMS agency's feedback requirement and before the commenting deadline.

The Shared Savings Program NPRM will appear in the April 7, 2011 issue of the Federal Register. CMS will accept comments on the proposed rule until June 6, 2011 and will respond to them in a final rule to be issued later this year. The Shared Savings Program will begin operating on January 1, 2012.

I have three immediate family members on coumadin for whom I am trying to get them switched to Pradaxa and we don't need more roadblocks. Two of them are suffering bone pain from bone spurs which I suspect is due to Vitamin K deficiency secondary to the coumadin antagonist effects. We depend on credible professionals like you to present your case to this new bureaucracy to protect us from our government.

Thanks again for your post and in advance for following up with the agency to voice your objections/modifications to this proposed rule,

I work in the healthcare industry and I also worked in pharma. And Ive lived in both Canada and the US, though Ive lived most my life in MI.

I like the fact you're highlighting some of the great reasons pradaxa might be a good product for certain patients. Most drugs have associated risks and concerns like unmanageable bleeding are quite important to consider when looking at the patient We as consumer patients often choose our own doctors and our choice in meds if we can afford it - and if I had other interactions or was not going to check-ups for INR, I hope my doctor would consider alternatives. We can look at many other "fancy" products on the market and access is of course controlled by our PBOs. Sure, that fancy drug might be expensive, but they fail to see that it could replace other medications, stop additional testing or visits and save them money in the long run. It's the $ upfront cost they look at.

For those patients that pradaxa MIGHT be better for, it's quite sad that governmental control would not allow a person to potentially gain access to something that might change their life for the better and avoid the additional costs of monitoring INR and repeat office visits. I know doctors that have Coumadin clinic DAYS each week to handle all their patients they monitor. Imagine being able to free up more of their time to see more patients.

Ok so a system based on reaching everyone - good but bad. We get these patients seen, but we also limit the potential meds and treatments suggested. My fiance in Canada may wait an entire day in the ER (if not serious) to see a doc. He plans to take a half to full day off to see a doctor at the clinic. Many Canadians love their service, but the doctors there do see abuse of the system and underpaid medical staff compared to their counterparts. One doctor in Quebec suggested that if there was, say a $5-$10 co-pay, it would make people think twice about abusing the system and only going to see a doc when they need to. Thanks for voicing about this on your blog!

I've been on Coumadin, and have had problems with keeping a steady INR at times, too low, too high, and then I do something that I shouldn't like eat a huge spinach salad, and test two days later perfectly where they want it.

I'm now on Pradaxa. No more monthly, weekly, biweekly trips to get tested, no having to remember when I'm scheduled. It took me two bottles before I had the habit down of taking it with my morning and night meds, since you aren't allowed to keep the pills out of the bottle unless you're taking them (I did that for two weeks before I read and caught that little point, the doctor didn't warn me).

I'm saddened about the ACO.

I'm also surprised that they don't have a reversing medicine for it yet. With my high BP (usually under control), a hemmorhagic stroke is a good possibility, especially when I do get angry (hard, but certainly not impossible to do).

My kidneys aren't what they should be either, so I'm on the lower dosage. But after four ablations and a couple of cardioversions (each one shorter laster at keeping me in rhythm than the previous one), I'm running with a pacer, and my heart function is back to normal, praise God!

And on the other hand, I'm not taking rat poison any more.

Anonymous @10:27, I was taking 5mg/day, with some days 7.5mg. There is no standard dose for warfarin, it depends a lot on your genetics and your diet. And that can change (sometimes for no apparent reason), so you need to keep testing, especially once you're "normal" dose is found, which will vary from time to time.

money, money, money, it's all about money, pockets quite slick, need constant grease, in the form of the greenback we seldom get to keep...as long as it comes in and we are forced to pay, money money, money, will guide the healthcare of today.. maybe in the future.. the care and well being of our people will come out on top... and the slick, green grease will be on the hills, in the form of grass we can slide down and enjoy... Kim Lorton 2011

We just received a trauma patient in our ER who is on Pradaxa. Almost lost him because of our inability to reverse Pradaxa's effects. What would you rather not do: Bleed or check your INR levels on a regular basis?

6 months ago My Granmother a sprite healthy active 90 yr old, not on coumadin , was given Sotalol due to her complaining of dizzyness to her cardiologist, She had this 7 yrs and no falls, injurys, just a bit hypochodriac if anything, She always ate Turkey, veggies walked sevaeral miles a day briskly about the neighborhood, shopped, etc, Well they gave both drugs to her and sent her home uninformed or warned etc as was protocol and she never did get that info until after home from her 1st intensive care stay and 6 transfusions over 8 days there, followed by another 4 day stay and 2 pints blood and 1 plasma , She should have never beensent home for Sotalol alone and with the Pradaxa over 75 is risky and should be monitored as well, They ignored our cals to them until I had to carry her in weak and out of blood, 6 pints in a 104 lb woman! 6 months later, her stomach hurts, cant eat much, is weakened and blleding still , anemic, lost weight, no longer able to walk without a walker, or alone anywhere, I feel they almost killed her pbviously and more than 1 Dr said it was insanity to give a 90 yr old these drugs and at home too! they would never do so for them or loved ones!! I was amazed at the Drs candid opinions! the hospitalist was shcoked, he never saw anyone who had taken this drug, nor overdosed as well! and said there is no remedy or counteractant. She was conned into being a guienea pig and would nevertaken this had she known the facts as to how newe and few had taken this drug, sure for some younger people MAYBE its ok? but with coumadin easily counteracted and decades use, and cheaper why go to this drug that does require monitoring , how they can say it does not at this point is beyond me, clearly they know lawsuits are in the tube big time and are avoiding its use to save $$

My 75 year old mom has been on warfarin for several years, along with tambocor and verapamil... This past spring she began experiencing severe itching and rash. Some criticisms of warfarin have listed this as a long term side effect of warfarin and there was nothing new in her diet, or medicines to otherwise account for these symptoms. The best her doctor suggested was skin lotion (very short term relief and soon stopped working at all) and, when her itching caused infection and swelling, antibiotics and prednisone...

I found information online about Pradaxa, at the same time, she'd seen the television ads and we thought it would be worth a try... and it was approved by her doctor and insurance... She's about to start taking Pradaxa, but now I'm worried about these side effects.

Obviously everything has side effects (for someone...), but this is confusing and frightening.

Is Pradaxa basically just a replacement for Warfarin, or is it only for people with Afib? I have Factor V Leiden deficiency with a history of DVT and have been taking Warfarin for ten years, and keeping a stable INR is nearly impossible. Is this something that I could potentially take in lieu of Warfarin?

Encountered first patient on Pradaxa while evaluating for surgery. She is on the medication for AFIB in lieu of coumadin. Her cardiologist recently performed an ablation procedure and ran into bleeding complications. He advised I stop the medication for 1 week instead of the recommended 1-2 days prior to my procedure. the inability to reverse the drug easily should the patient encounter bleeding appears to be a major problem with the drug despite the improvement in QOL for the patients.

Thank you for presenting the pros and cons of Pradaxa on this website. I wish my husband and I had known that there is no reversal antidote for Pradaxa. His local cardiologist put him on Pradaxa last Feb. Three weeks later he got the call for a heart transplant. He had been on the list for three years. The transplant doctors had not even heard of Pradaxa when we got to UVA. My husband decided to go ahead with the transplant even though the UVA docs told him it would be riskier because of Pradaxa. He was afraid he would die while waiting for another heart. Unfortunately he died from severe bleeding complications during the transplant. I wish doctors were required to tell patients that problems can be severe or fatal if emergency surgery should be required. My husband's last dose of Pradaxa was 24 hours before surgery. Clearly, this window of time was not large enough.

My mother was on coumadin since 2005 for Afib and also has a pacemaker. She started pradaxa in January 2011. She experienced few if any side effects and although her thin skin bruises very easily the bruising is much less severe and healing time is amazing. Three days ago she suffered a GI bleed. Of course she was admitted to hospital but because she was on pradaxa, her ONLY option was a CT scan. The GI doc and her primary doc informed me that NO surgeon would touch her knowing she was on pradaxa. Thank goodness her bleeding stopped on it's own. My mother is now BACK on coumadin and we are going to consult a nutritionist to create a meal plan to help control her diet. Please realize that even if a pradaxa patient falls and breaks a hip or has a serious injury THEY CANNOT BE TREATED FOR AT LEAST TEN DAYS!! And then your lucky if you find a dr that will take the risk. How can a drug company be permitted to sell a drug with no reversibility?

Thank you Dr Wes for responding! Unfortunately, while this information may be tried and true in clinical studies, surgeons in the real world are not convinced - nor willing to take that chance. Would you?

Warfarin kills more patients than ANY prescription medication.We move to new drugs for 2 reason....less morbidity, or less mortality. Dabigatran was statistically superior for morbidity (Stroke/Sys. Embolism) as well as having a stastistically significant reduction in vascular death, in trial 3x larger than all the trials for Warfarin combined Seems simple to me.

I decided on Pradaxa last Feb., 2011. I had struggled taking Coumadin to get my blood thinned to where my cardiologist wanted it and I tired of the frequent dosage adjustments and getting stuck with the darn needles. Pradaxa seemed like my answer and I asked my doctor about it and he approved. The first week of December, 2011, I entered the hospital with A-Fib. I had previously been in in October 2011 for an A-Fib problem but blood levels were fine and I underwent cardioversion to get it back in rhythm. This time they found I was very anemic and was given 3 units of blood over 3 days. The problem? Internal bleeding in the small intestine and it had been going on for quite a while. I had noticed some blood in the stool but like a dummy, didn't get it checked. I was taken off Pradaxa immediately. It had apparently caused some small fissure or something to bleed over several months and it was getting worse. After spending several days in the hospital, undergoing a colonoscopy and endoscopy, I'm awaiting a camera pill procedure in two weeks. I feel much better and feel lucky that things worked out the way they did. The only thinner I'm on for the time being is 81 mg of aspirin once a day. Stay away from Pradaxa. It can cause a bad bleeding problem in some people or even complications with much worse results!

Hi, I was on warfarin for a dvt and was on clexane injections until my inr reached appropriate levels. I became allergic to the clexane and so was referred to a haemotologist to see what i could take. He gave me pradaxa to take with the warfarin.Two hours after taking one pradaxa tablet, i had a subarachnoid haemorrage. I was then urged by the neurologist in the hospital to resume the pradaxa. Luckily i refused as i knew my bleed was linked to the pradaxa. I'm so glad i asserted myself on that. I am 42 and have had no other medical problems before this. I hate this drug, it could have killed me. I for one would much rather have regular blood tests and stay on warfarin. Oh and the trauma that caused my bleed... Putting my head on my pillow to go to sleep!

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.